CMF Distraction System - Mandible Cloverleaf Foot, AB & BC Craniofacial Distractor Body (2019-11-28)
- Starting date:
- November 28, 2019
- Posting date:
- January 10, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72069
Last updated: 2020-01-10
Affected Products
- CMF Distraction System - AB Craniofacial Distractor Body
- CMF Distraction System - BC Craniofacial Distractor Body
- CMF Distraction System - Mandible Cloverleaf Foot
Reason
The products subject to this action are being removed from the market to prevent any future potential incompatibility with devices being re-designed and re-introduced into the CMF distraction system.
Affected products
-
CMF Distraction System - AB Craniofacial Distractor Body
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 04.315.003
- 04.315.004
- 04.315.005
- 04.315.006
- 04.315.053
- 04.315.054
- 04.315.055
- 04.315.056
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
Colorado
UNITED STATES
B. CMF Distraction System - BC Craniofacial Distractor Body
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
04.315.023
04.315.024
04.315.025
04.315.026
04.315.027
04.315.028
04.315.063
04.315.064
04.315.065
04.315.066
04.315.067
04.315.068
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
Colorado
UNITED STATES
C. CMF Distraction System - Mandible Cloverleaf Foot
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
04.315.211
04.315.212
04.315.213
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
Colorado
UNITED STATES